Bardex® Lubricath® Foley Catheter 0167L16Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741018947), received between Mar 23, 2020 and Oct 6, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, DURING PRETESTING FOLEY CATHETER HAD ONE-SIDED SWELLING AND STERILE WATER LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221292 ↗
• MalfunctionJun 12, 2025Wrong Label; Wrong Label

  IT WAS REPORTED ABOUT INCORRECT BARCODE ON THE FOLEY CATHETER PRODUCT. THIS PRODUCT WAS DELIVERED TO, BUT THERE WAS SOME CONFUSION ABOUT THE EAN CODES FOR THE UNIT AND THE 10-PIECE PACKAGING. THESE SHOULD BE THE SAME FOR BOTH PACKAGES. THE SAME BARCODE IS PRINTED ON BOTH THE BOX AND THE PRODUCT, BUT WHEN SEARCHED FOR IT IN THE SYSTEM, IT SHOULD BE AS FOLLOWS: MATERIAL ALTERNATIVE UNIT OF MEASURE COUNTER EAN/UPC 226716, EA 1, (B)(4), 226716, SP 10, (B)(4) OR DO THE LAST TWO DIGITS NOT COUNT?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194588 ↗
• MalfunctionApr 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE THE PROCEDURE HAD BEGUN, THE SURGEON WITHDREW FOLEY CATHETER A BIT AND NOTICED THE FOLEY WAS BROKEN 11 CM FROM THE TIP OF THE FOLEY IN WHICH 11CM WAS INSIDE THE PENIS. FOLEY CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133419 ↗
• MalfunctionFeb 15, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT ON (B)(6) CVP DETENTION WAS DONE AT OPERATING ROOM AND ON (B)(6) NATURAL REMOVAL WAS DONE. IT WAS STATED THAT THEY CONFIRMED THAT THE BALLOON WAS DAMAGED. A SUPPLEMENT TO THE TWO INCIDENTS THAT OCCURRED IN THIS MONTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711887 ↗
• MalfunctionFeb 14, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED AFTER AN OPERATION WAS PERFORMED, BUT WAS DISLODGED. UPON CHECKING THE BALLOON, IT WAS FOUND THAT THE BALLOON HAD RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702369 ↗
• MalfunctionOct 20, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER SPONTANEOUSLY FELL OUT. THE CATHETER WAS PLACED ON THE PATIENT AFTER CENTRAL VENOUS PRESSURE OPERATION ON (B)(6). ON (B)(6), IT SPONTANEOUSLY FELL OUT WHILE TAKING A SHOWER. AS PER NOTIFICATION RECEIVED FROM IBC REPRESENTATIVE ON 12OCT2023, STATED THAT THIS ISSUE WAS BALLOON RUPTURE SINCE THE BALLOON RUPTURE WAS OBSERVED TO THE RETURNED SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981554 ↗
• MalfunctionMar 24, 2020Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WERE SEVERAL FAULTY CATHETERS FROM THE SAME BATCH: THE EYELETS FROM ONE OF THE CATHETERS WERE NOT UNIFORMED, THE BALLOON FROM ONE CATHETER INFLATED ON ONE SIDE, AND ONE OF THE CATHETERS WAS FOUND KINKED/BENT UPON REMOVAL. REPORTEDLY, ALL OF THE EVENTS CAUSED UNNECESSARY DISCOMFORT AND PAIN TO THE PATIENTS.

  Patient problems: Discomfort; Pain

  MAUDE report 9871082 ↗
• MalfunctionMar 24, 2020Dent in Material; Failure to Form Staple; Material Twisted/Bent; Dent in Material

  IT WAS REPORTED THAT THERE WERE SEVERAL FAULTY CATHETERS FROM THE SAME BATCH: THE EYELETS FROM ONE OF THE CATHETERS WERE NOT UNIFORMED, THE BALLOON FROM ONE CATHETER INFLATED ON ONE SIDE, AND ONE OF THE CATHETERS WAS FOUND KINKED/BENT UPON REMOVAL. REPORTEDLY, ALL OF THE EVENTS CAUSED UNNECESSARY DISCOMFORT AND PAIN TO THE PATIENTS.

  Patient problems: Discomfort; Pain

  MAUDE report 9871078 ↗
• MalfunctionMar 23, 2020Misassembled; Material Deformation; Material Twisted/Bent; Misassembled

  IT WAS REPORTED THAT THERE WERE SEVERAL FAULTY CATHETERS FROM THE SAME BATCH. THE EYELETS FROM ONE OF THE CATHETERS WAS NOT UNIFORMED, THE BALLOON FROM ONE CATHETERS INFLATED ON ONE SIDE, AND ONE OF THE CATHETERS WAS FOUND KINKED/BENT UPON REMOVAL. ALL OF THE REPORTED EVENTS ALLEGEDLY CAUSED UNNECESSARY DISCOMFORT AND PAIN TO THE PATIENTS.

  Patient problems: Discomfort; Pain

  MAUDE report 9868084 ↗